Cell & gene therapy manufacturing
I've worked inside two commercial CAR-T manufacturing programs at leading pharma and biotech companies. I know what these programs need because I've built them.
The challenge
Cell therapy manufacturing is uniquely demanding. Every batch is a single patient. The consumables your process touches - bags, tubing, connectors, media containers - directly contact patient cells. And the regulatory bar for these materials is rising fast, with USP <665> now mandatory and FDA scrutiny on single-use systems increasing.
Whether you're running a manual cleanroom process or transitioning to an automated platform like CliniMACS Prodigy, Cocoon, or a custom system, the materials qualification challenge is the same: you need formal specifications, biocompatibility data, E&L testing, supplier qualification, and GMP documentation for every product-contact consumable.
Why me
I've done this work at two of the leading CAR-T programs. At one, I was the global point of contact for single-use plastic materials across manufacturing sites - managing material impact assessments, supplier changes, and alternate qualifications. At another, I led the entire consumable qualification program for an automated manufacturing transition, covering 10+ ISO 13485 suppliers and a 9-phase qualification framework that was the critical path for the regulatory filing.
How I help
Consumable qualification
End-to-end qualification of single-use bags, tubing, connectors, and assemblies. Risk assessment, materials testing, documentation.
Supplier management
Qualification of ISO 13485 contract manufacturers. Quality agreements, specifications, incoming inspection, monitoring.
E&L testing
Risk-based extractables and leachables strategy per USP <665> and ISO 10993. Protocol development and CRO coordination.
GMP readiness
Supply chain gap assessment, documentation completeness review, and regulatory filing support for PAS, BLA, or IND.
Material risk management
BOM-level FMEAs, concentration risk mitigation, change impact assessments under ICH Q5E comparability.